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Trial record 58 of 272 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)

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ClinicalTrials.gov Identifier: NCT03846895
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Themos Grigoriadis, National and Kapodistrian University of Athens

Brief Summary:
This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

Condition or disease Intervention/treatment Phase
Overactive Bladder (OAB) Device: Microablative Fractional CO2 laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
Actual Study Start Date : May 12, 2018
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laser Group

Microablative Fractional CO2 laser therapy at monthly intervals.

The laser parameters that will be used are the following:

  1. Power: 40 watts,
  2. Dwell time:1000μs,
  3. Spacing 1000 μm,
  4. Depth: SmartStak parameter 3
  5. D-pulse mode.
Device: Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals
Other Name: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy

Placebo Comparator: Placebo Group

Placebo CO2 laser therapies at monthly intervals.

The laser parameters that will be used are the following:

  1. Power: 0.5 watts,
  2. Dwell time:1000μs,
  3. Spacing 1000 μm,
  4. Depth: SmartStak parameter 1,
  5. Smart-pulse mode.
Device: Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals
Other Name: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy




Primary Outcome Measures :
  1. Overactive Bladder questionaire (OAB-q) [ Time Frame: 24 months ]
    It consists of an 8 item symptom bother scale section and a 25 item health related quality of life scale section (HRQL). Scores of each domain of the 2 sections range from 0 to 100. Higher scores indicate higher impact of overactive bladder symptoms.

  2. 3 days voiding diary [ Time Frame: 24 months ]
    Assesses bladder function (frequency of micturition, urgency and urinary incontinence)


Secondary Outcome Measures :
  1. King's Health Questionnaire (KHQ) [ Time Frame: 24 months ]
    It has 3 sections: 1) general health and overall health related to urinary symptoms with 2 questions, 2) incontinence impact, role limitations, physical limitations, social limitations, personal limitations, emotions, sleep and energy, and severity coping measures with 19 questions and 3) bother or impact of urinary symptoms with 11 questions. Scores of each domain of the 2 sections range from 0 to 100. Scores of the third section range from 0 to 3. Higher scores indicate higher impact of urinary incontinence.

  2. Patients Global Impression of Improvement (PGI-I) [ Time Frame: 24 months ]
    It is a single question with 7 possible answers. Patients will chose the answer that applies at their impression of improvement after the laser therapy

  3. Urogenital Distress Inventory questionaire (UDI-6) [ Time Frame: 24 months ]
    It is a 6 item questionaire evaluating symptom distress of urinary incontinence and its impact on daily life. Scores range from 0 to 100. Higher scores indicate higher impact of urinary incontinence.

  4. Pelvic Floor Impact Questionnaire—short form 7 (PFIQ-7) [ Time Frame: 24 months ]
    It is a 7 item questionaire evaluating how much bladder symptoms affect their activities, relationships, and feelings.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
  • Overactive bladder syndrome (OAB)

    • ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h
    • At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.

Exclusion Criteria:

  • Participants with:

    • Pelvic Organ Prolapse (POP) > stage II of the pelvic organ prolapse quantitation system (POP-Q)
    • Post void residual volume > 200 ml (measured by ultrasound)
    • Use of moisturizers or lubricants the last month
    • Use of vaginal estrogen in the last 6 months
    • Use of drugs for urinary incontinence
    • Use of psychotropic drugs
    • Symptomatic urinary tract infection
    • Active genital infection
    • Kidney or liver disease
    • Abnormal cardiac conduction, rate or rythm disorders
    • Diabetic neuropathy
    • Myasthenia gravis
    • History of malignant disease
    • Previous radio-chemo therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846895


Contacts
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Contact: Stavros Athanasiou, Associate Professor +306944478555 stavros.athanasiou@gmail.com
Contact: Konstantinos Kypriotis, MD +306946150887 kypriotisk@gmail.com

Locations
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Greece
Urogynecological Unit of Alexandra Hospital Recruiting
Athens, Greece, 11528
Contact: Stavros Athanasiou, Prof.    +306944478555    stavros.athanasiou@gmail.com   
Contact: Themos Grigoriadis, Assist. Prof.    +306948741306    tgregos@yahoo.com   
Principal Investigator: Stavros Athanasiou, Associate Professor         
Sub-Investigator: Themos Grigoriadis, Assistant Proffesor         
Sub-Investigator: Konstantinos Kypriotis, MD         
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Themos Grigoriadis, Assistant Professor National and Kapodistrian University of Athens

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Responsible Party: Themos Grigoriadis, Assistant Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03846895     History of Changes
Other Study ID Numbers: 303/16-04-2018
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms